a study of belumosudil in people at risk of developing graft-versus-host disease after a stem cell transplant

Conditions: Graft Versus Host Disease; Graft Vs Host Disease; Hematologic Malignancy

Summary: the purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (gvhd) may be an effective gvhd prevention approach for people with blood cancer who have a stem cell transplant. the investigators will also look at the safety of the study approach.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years-old at time of consent. * diagnosis: hematologic malignancy in morphologic remission who will be treated with ri or nma conditioning and gvhd prophylaxis cni-based (cni without ptcy) plus abatacept or ptcy-based (cni with ptcy). * recipients of 7-8/8 related or unrelated hla-matched or related haploidentical donor. * peripheral blood stem cell graft * allo-hct day \<120 at time of consent post-hct inclusion criteria (within 3 weeks before start of belumosudil treatment) * patient has received an allo-hct transplant and is in morphologic remission (blasts \<5%, no evidence of extramedullary disease in aml or mds). patients with cr with incomplete count recovery (crp or cri) or minimal residual disease are allowed. * patient has achieved engraftment. engraftment is defined as anc≥500/μl and platelets ≥ 20000/μl on 3 consecutive measurements (each occurring at least 1 day apart). the patient must not have had a platelet transfusion within 7 days before the first measurement. * patient is ≥ 80 days and ≤ 20 days from allo-hct infusion. * karnofsky score ≥ 70%. * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3x upper limit of normal (uln) * total bilirubin ≤1.5 x uln (unless benign congenital hyperbilirubinemia). * glomerular filtration rate (gfr) ≥ 30 ml/min/1.73 m2 * female subjects of childbearing potential (≤ 50 years old) have a negative serum or urine pregnancy test. females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months. ° sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. effective birth control includes: \* intrauterine device (iud) plus one barrier method \* stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method \* 2 barrier methods. effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \* a vasectomized partner * for male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug. exclusion criteria: * recipient of cd34+ selected or engineered stem cell graft. * treatment with in vivo t cell depletion (e.g. anti-thymocyte globulin). * evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. * pulmonary dysfunction with dlco \<50% corrected for hemoglobin post-hct exclusion criteria * uncontrolled infection, including active hepatitis b and c. definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment. * use of investigational agent within 14 days pre-hct or anytime thereafter. * active acute or chronic gvhd requiring systemic therapy (topical or local therapies are allowed). * active treatment with corticosteroids at a dose of ≥ 0.25 mg/kg/day for non-gvhd indication. * uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year * female patient who is pregnant or breastfeeding. * prior therapy with belumosudil. * known allergy or sensitivity to belumosudil or any other rock2 inhibitor.

Keywords: graft versus host disease graft vs host disease hematologic malignancy hematologic malignancy in morphologic remission belumosudil stem cell transplant memorial sloan kettering cancer center 25-033